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Johnson & Johnson キャリア

【Janssen】 R&D Japan JSS, Safety Risk Management Dept. PV Associate (Staff)

千代田区, 日本
Drug & Product Safety Science


仕事内容

Requisition ID: 1905766563W

JOB SUMMARY:

Take full responsibility to prepare Japan Risk management Plan (J-RMP) and implement all activities related to risk management under GVP and GPSP in responsible products/compounds

 
KEY RESPONSIBILITIES:

Take full responsibility to create, implement and verify J-RMP including all risk minimization activities for EPPV, risk communication activities and aggregate reporting such as J-DSUR, J-PSUR, Periodic Infection Report and Non-serious unlisted periodic report including reports for medical devices of responsible products/compounds.

・Take full responsibility to prepare and assess a summary of aggregate reports, revision of package inserts, Reexamination dossier, GPSP compliance inspection, Early Post-marketing Phase Vigilance, responses to regulatory inquiries, and others.

・Collaborate with members of JRML and PMSO for above mentioned activities in responsible

products/compounds.

・Take a role as a core J-SMT member in collaboration with JPKK’s key stakeholders including JCoT members in responsible products/compounds.

・In a way that supports JRML, liaise with all other internal and external key stakeholders of responsible products/compounds..

・Join related committee including partner companies as a representative of J-SMT of responsible

products/compounds.

・Plan and monitor budgets and controls expenditures for responsible products/compounds in collaboration with JRML and Strategic Risk Communication Group.



資格
REQUIREMENTS:
Experience/Knowledge

・5-year or more experiences in pharmaceutical industries are generally recommended.

・Scientific & medical knowledge including medical writing skill and local regulations, GVP and GPSP.

Skills/Capabilities

・Strong leadership including decision making, management, negotiation, stakeholder management and communication skills necessary.

・Ability/competency to show contentious proposals to responsible teams and groups.

・English communication skill (TOEIC 600 point and above), verbal, writing, presenting and facilitating.

Qualification/Certificate

・A BA degree in a biological or medically related field is preferred



プライマリ場所
日本-東京都-千代田区-
組織
Janssen Pharmaceutical K.K. (7195)
ジョブ
Drug & Product Safety Science
Requisition ID
1905766563W